Monday, April 20, 2009

Why Is Industry So Scared of Finding Out What Really Works?

In a previous post: http://brodyhooked.blogspot.com/2008/08/massachusetts-gift-law-industry-took.html, I suggested that the way to find out what the drug industry really is thinking is to find out what they are fighting the hardest to avoid. (At that point, it was about how the Massachusetts state house was overrun with Pharma lobbyists when it considered a bill to require open reporting of and strict limits on payments to physicians.) This would sound terminally paranoid were it not for the fact that the drug industry is so slippery--they have become so used to never saying what they really mean, that you have to search for all sorts of indirect clues as to what might be on their minds.

So my esteemed colleague Marilyn Mann is surely onto something by passing along this news report: http://www.bloomberg.com/apps/news?pid=email_en&sid=aHjr0BP1zvgo, which basically shows how several big companies are hurriedly adding more lobbyists to fight against the Obama administration's plans to include comparative effectiveness research of pharamceuticals as a part of the economic stimulus package. We might ask: Just what is it about comparative effectiveness research that so frightens Pharma?

Some previous opinion pieces and news reports have distinguished between comparative ("head to head") trials which simply try to establish the superiority of one treatment over another, as opposed to those that explicitly take cost into account. Then the industry opposition is focused on the latter. From that example, it would seem that the industry is deathly afraid that we might figure out that some very slight improvements in outcomes are being purchased only at huge increases in cost. They'd much rather, for example, that we know that a new chemotherapy drug prolongs the life of the average cancer patient by 2 months; but not that it costs $150,000 to get that extra 2 months of life.

Now the argument against comparative effectiveness research (with or without costs explicitly taken into account) is based on one possible use of the resulting data, which we have to admit might actually occur. The sequence would go as follows:

Comparative effectiveness research is carried out on drugs A vs. B.

The research shows that drugs A and B are roughly equivalent in outcome, but B costs less.

If you look very carefully at the research findings, you'll see that the average outcomes obscure a good deal of individual variability. A sizeable minority of patients actually do better on drug A.

However, the payer for care (the government in the most-feared scenario; private insurers in today's scenario) seizes upon the uncritical reading of the data from the trial, and issues guielines that demand that physicians use drug B and that essentially eliminate any payments for drug A.

Bottom line--a significant number of patients are denied the drug that would most help them, just so the skinflint insurers can save a few bucks.

As I say, this could happen, and occasionally has. But we need to notice that there are a number of intervening steps between the actual conduct of the comparative effectiveness trial, and the result that we find so upsetting. If the drug industry was focusing its lobbying efforts on those intervening steps, we could have more sympathy for them. But it's noteworthy to me that they are aiming all their big guns at the very first step in the process--long before anyone has drawn inappropriate or simplistic conclusions or constructed straitjacket clinical guidelines.

Against the drug company orchestration of outrage are the moderate voices of good sense. Physicians today are starved for good data on what treatments work better than others--since more than 80 percent of trials of drugs are industry sponsored, and industry overwhelmingly chooses to compare drugs to placebo and not to already effective treatment. Everyone (except maybe the pharmaceutial industry) agrees that we can only have a sustainable health system in the future if we can rein in costs. If we want docs to help us to save money, it makes a heckuva lot more sense to ask them to save us money by doing less of what doesn't work, instead of trying to deny them the data about what works better or worse.

Against these voices of reason, drug companies are reduced to doing much what the AMA had to do in the 1960s when it tried to fight the Kefauver-Harris amendments that gave the FDA the responsibility to test the effectiveness and not just the safety of new drugs. The AMA was forced in that instance to act like scientific Neanderthals. They had to claim, for all intents and purposes, that the average physician in the boondocks was just as capable of deciding what drugs are effective as the scientist conducting a multicenter clinical trial. They had to claim that anecdotal evidence was just as good as any randomized controlled study. Similarly, today the drug industry has to stress how different everyone is from everyone else, so that the average results of comparative effectiveness trials are sure to be misleading. This of course, taken to its logical conclusion, undermines any reliance on evidence-based medicine.

I conclude from this sorry spectacle that the drug industry--which shouts so loudly that when it markets its drugs to physicians, it's really engaged in "education"--is in fact deathly afraid that we will someday find out how effective its expensive new drugs really are. That bodes very poorly for what we haven't yet found out amidst the marketing smoke screen that the industry has managed to proliferate around its products.

Howard, Great blog. You state that Pharma companies choose to compare to placebo instead of comparators, but doesn't FDA prefer placebo controls at least for NDAs? Of course, what FDA prefers might very well reflect what sponsors wish to provide.

Hello there, my name is Amanda. i viewed your blog via a facebook post. I am very interested in your effort to hold drug companies accountable. i am even more interested in your thoughts on the accountability of physicians. I am looking for some one to help me write a book based on my mother's life. She passed away from a narcotic drug addiction in October 2007. If you could please help me i would greatly appreciate it. I have done some research and found that there is not much on the market right now regarding this issue. My mom was 45 when she died. She was very sick, and I feel that the lack of physician accountability, lack of awareness of this issue and my mother's addiction ultimately ended her life. I am interested in using her story to bring awareness to this issue and to provide those of us grieving with a book to read and reflect upon.

I hope that I have sparked some interest in you and that you may be inclined to contact me to discuss the details further.

I like your comment about following what pharma is doing rather than saying. As you said in an earlier post they usually ignore the 'pharmascolds' if they are just writing about medical ethics because it does not affect their bottom line, but if someone says their blockbuster is unsafe they pull out the guns big time and let their PR firms clean up the mess later. That is because it threatens their profit line, which is what drives their behavior.